At the end of 2019, a novel coronavirus was identified as causing cases of severe pneumonia in the city of Wuhan, which is in the Hubei Province of China. The new disease called COVID-19 was identified as caused by a novel virus named SARS-CoV-2, given its genetic resemblance to the SARS coronavirus that caused a similar outbreak that originated in China in 2003, and which had a 10% mortality rate. The World Health Organization in March 2020 declared COVID-19 to be a global pandemic but well before this Vaxine scientists were already hard at work from January 2020 onwards creating a vaccine against COVID-19 based on lessons learned from our experience previously developing successful SARS-CoV and MERS-CoV vaccines. While Vaxine initially developed DNA, RNA, and protein-based COVID-19 vaccines, we rapidly settled on the recombinant protein-based platform as having the best promise from both an effectiveness and safety perspective, given the extensive experience over the last 40 years with other FDA approved recombinant protein vaccines. Using modeling approaches Vaxine scientists rapidly confirmed that the COVID-19 spike protein binds the same receptor as SARS-CoV, namely the human angiotensin-converting enzyme 2 (ACE2) to gain entry into human cells making the spike protein the key target antigen for the development of our vaccine, now named COVAX-19® vaccine. COVAX-19® vaccine comprises a recombinant spike protein antigen formulated with Vaxine’s proprietary Advax-SM adjuvant, which drives a potent T-cell and neutralizing antibody response against the target virus.
COVAX-19® vaccine has been shown to be highly immunogenic in mice, macaque monkeys, and ferrets. Following the successful preclinical studies, the Phase I human clinical trial of COVAX-19® vaccine was started on June 30, 2020. COVAX-19® was the first Australian vaccine candidate to commence human clinical trials. This study was independently conducted by the PARC clinical trial team at the Royal Adelaide Hospital and involved 40 healthy participants who were randomised to either active vaccine (30 participants) or saline placebo (10 participants). Preliminary data of this Phase I clinical study demonstrated that the COVAX-19® vaccine is safe, well-tolerated, and immunogenic. The Phase I study protocol is available on clinicaltrials.gov (identifier, NCT04453852) and its detailed results will be published soon.
With these promising preclinical and Phase I clinical data, we are now seeking to advance into a Phase 2/3 clinical trial in collaboration with companies and organisations worldwide.